Executive Director, Biometrics

🕒 il y a 1 mois

🌲 North Carolina – Distant

🌲 North Carolina – Remote

⏰ Temps Plein

🔴 Expert

👔 Directeur

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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BioCryst Pharmaceuticals, Inc.

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501 - 1000 employés

🏥 Santé

💼 Conseil

📦 Logistique

💰 €450 000 000 Post-IPO Debt - BioCryst Pharmaceuticals en 2023-04

Healthcare • Consulting • Logistics

BioCryst Pharmaceuticals, Inc. est une entreprise mondiale de biotechnologie spécialisée dans la découverte, le développement et la commercialisation de nouvelles petites molécules orales et de thérapies protéiques pour les maladies rares, notamment l'œdème angioneurotique héréditaire (OAH). Fondée en 1986, BioCryst utilise la conception de médicaments guidée par la structure, la chimie médicinale et les technologies avancées pour développer des médicaments de première classe ou de meilleure classe, et travaille en étroite collaboration avec les patients, les associations de patients et les partenaires mondiaux pour mettre les traitements sur le marché.

Description

• Lead the conduct and analysis of BioCryst-sponsored clinical studies from Phase I to Phase IV and selected non-clinical studies • Provide Biometrics support for clinical studies, selected non-clinical studies, and Medical Affairs • Ensure relevance and adequacy of statistical methods and conformance to regulatory guidelines and Good Clinical Practice • Contribute to clinical development strategies, development programs, and study design • Oversee CRO and contract staff performing outsourced operational activities • Review and approve contracts, work orders, and invoices within delegated authority • Act as project statistician for an individual project • Participate in FDA and other regulatory agency meetings as the company’s biostatistical spokesperson • Define, create, and implement organization-wide processes focused on efficiency and productivity • Define, monitor, and evaluate relevant performance metrics • Author and review statistical and biometrics sections of protocols, statistical analysis plans, data management plans, regulatory documents, NDAs, MAAs, regulatory responses, abstracts, and manuscripts • Ensure accuracy of clinical trial data in public corporate communications, including press releases, presentations, SEC filings, abstracts, and manuscripts • Monitor the quality audit process for public clinical trial communications • Communicate technical concepts to technical, regulatory, and broader nontechnical audiences • Identify, evaluate, and implement new biostatistics and programming processes and technologies • Develop and align outsourcing strategy with Clinical Development goals • Perform additional duties as assigned

🎯 Exigences

• Ph.D. in Biostatistics or related field with at least 12 years’ experience in the pharmaceutical industry, 10 or more years’ experience in the design, analysis and interpretation of clinical trials, or an equivalent combination of education and experience • Deep understanding of SAS programming sufficient to provide oversight of statistical programming and ability to program as needed • Strong leadership and interpersonal skills • NDA filing experience as a key contributor to one or more successful product approvals • Proven expertise in biostatistics, programming, and clinical data management, including development and accountability for relevant quality management systems • Demonstrated knowledge of the clinical development process and relevant regulatory guidelines and requirements • Experience with Data Monitoring Committees and/or study steering committees • Hands-on approach, including performing analyses when necessary • Excellent written and verbal communication skills • Ability to work well in a collegial environment and challenge the status quo • Experience with European and Japanese regulatory agencies • Formal expertise and experience in Bayesian and frequentist statistics • Flexible scheduling and ability to travel internationally • Responsiveness and ability to prioritize effectively

🏖️ Avantages

• Equal employment opportunity protections • Protected Veterans/Individuals with Disabilities status protections • Flexible scheduling • Opportunity to work on innovative first-in-class or best-in-class therapeutics • International travel opportunities

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